Hospitals and other health care facilities prepare and administer on a daily basis a significant number of parenteral solutions. These parenteral solutions include both nutritional as well as drug-containing therapeutic solutions. Because of the large number of such solutions which must be handled on a daily basis in a health care facility, efficient and accurate preparation and administration of such solutions is necessary.
A significant advancement in recent years has been the development of positive displacement fluid infusion pumping devices for intravenous or intramuscular administration of solutions to patients. Pump systems have replaced gravity flow control systems, primarily due to the greater accuracy in delivery rates and dosages of pumps, and the relative sophistication of processor controlled pumps in permitting flexible and controlled feed from multiple liquid sources. In particular, such infusion pumping devices permit precise control of drug administration to a patient over a given period of time.
The LifeCare.RTM. 5000 Drug Delivery System is a positive displacement fluid infusion pump that is currently manufactured by Abbott Laboratories and is widely used in the patient care field. U.S. Pat. Nos. 4,639,245, to Pastrone et al., 4,818,186, to Pastrone et al., and 4,842,584, to Pastrone, all of which are hereby incorporated by reference, disclose the above positive displacement fluid infusion pumping device and related components. The LifeCare Drug Delivery System for infusion pumping includes a pump driver and an associated removable and disposable pump cassette. The pump cassette includes a self-contained positive displacement pump component, which is operated for fluid movement by a reciprocable pump plunger of the associated pump driver. The pump driver further includes selectively operable valve actuators which cooperate with valve mechanisms in the pump cassette.. The LifeCare Drug Delivery System thus provides accurate and highly automated administration and infusion of parenteral solution.
There is a need for a solution pumping system including a disposable pump cassette which will permit the same highly-desirable efficiency, accuracy, and automation in the compounding and preparation of such parenteral solutions. While the needed system is particularly suited for preparation of small volume parenteral solutions, typically including drugs or other therapeutic agents for administration to patients, the principles are equally suitable for a system for preparation of large volume parenterals, typically comprising nutritional solutions for patients, as well as for use with other applications requiring compounding of multiple reagents or therapeutic agents.
Currently small volume parenteral solutions typically are prepared manually. The pharmacist selects an intravenous solution container, typically a flexible bag, that is either partially empty, or that contains the appropriate base nutritional solutions or diluents. The pharmacist then calculates the amounts of the various liquid components that need to be added to the solution container in accordance with the physician's order. These components are then measured by drawing them into syringes of the appropriate sizes. The contents of the syringes are then injected into the final solution container.
Accurate preparation of parenteral solutions in this manner is time consuming, typically taking 20-30 minutes per physician order, assuming about 10 minutes of preparation time per bag when making three bags with six solution additions per bag. While appropriate protocols are established and followed for accuracy and consistency, the manual nature of the procedure does not preclude the possibility of errors in the preparation of the resultant admixtures. Additionally, the repeated needle-puncturing and additions of solutions to the admixture container increase the risk of contamination.
The solution pumping system of the present invention, including a disposable pump cassette, is particularly configured to facilitate accurate and efficient compounding of parenteral admixture solutions with minimal labor and a reduced risk of contamination.